# FDA recall Z-1299-2021

> **Meridian Bioscience Inc** · Class II · device recall initiated 2021-02-08.

## Product

The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

## Reason for recall

Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.

## Distribution

US Nationwide distribution in the states of OH, SC.

## Key facts

- **Recall number:** Z-1299-2021
- **Recalling firm:** Meridian Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-08
- **Report date:** 2021-03-31
- **Termination date:** 2021-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cincinnati, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2021

## Citation

> MORVS. FDA recall Z-1299-2021. Retrieved 2026-11-03 from https://api.morvs.ai/recall/Z-1299-2021. Source: US FDA. Licensed CC0.

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